Trastuzumab, a drug to treat breast cancer, was developed by Roche. The court heard pleas from Roche and Indian pharma firms Biocon, Mylan and Reliance Life Sciences, on the issue of the sale and marketing of biosimilar drugs based on Trastuzumab.

Roche argued that it spent years of research and funding in developing Trastuzumab and conducting related tests and studies. Roche accused the Indian firms of including a copy of its research and studies in the package of their drugs. Roche further asserted that those companies should not be allowed to name their medicine as Trastuzumab, and they need to call it Biocon’s Trastuzumab or Mylan’s Trastuzumab.

Biocon and Mylan responded by saying that the Drugs Controller General of India (DCGI) asked them to quote the clinical data of Roche’s Trastuzumab in their respective package inserts. Biocon also stated that it manufactures the medicine for both companies, wherein Biocon sells it under the name Canmab and Mylan sells it under the name of Hertraz.

However, as Roche claimed that Biocon and Mylan’s package inserts were not approved by the DCGI, the bench asked to check and inform the court regarding the DCGI’s approval. Further, the bench was of the opinion that since the biosimilar medicine was made through an abbreviated process, companies like Biocon and Mylan need not go through the entire testing process again. Further, in a hearing on March 2^nd, the DCGI confirmed that the medicines and package inserts of Biocon and Mylan were granted approval. Hence, the court told Roche that it cannot have a say against the sale and marketing of the biosimilar drugs once the DCGI has given an approval.

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